MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE 23 G X 1 IN. SINGLE USE STERILE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305762
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd eclipse¿ needle 23 g x 1 in.Single use sterile the safety mechanism detached.There was no report of patient impact.The following information was provided by the initial reporter: whole entire needle guard snapped off before needle guard could close on the needle after vaccination was given.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 06-feb-2023.H6: investigation summary: our quality engineer inspected the 2 representative samples submitted for evaluation.The reported issue of safety shield broke off (eclipse) was not confirmed upon inspection and testing of the samples.Analysis of the sample showed that there were no abnormalities or damages present.The samples were then subjected to activation/locking force testing and passed the activation/locking force test.Bd could not determine a manufacturing related root cause since the returned samples did not show the reported defect.Production records were reviewed, and this batch meets our manufacturing specification requirements.
Event or Problem Description
It was reported while using bd eclipse¿ needle 23 g x 1 in.Single use sterile the safety mechanism detached.There was no report of patient impact.The following information was provided by the initial reporter: whole entire needle guard snapped off before needle guard could close on the needle after vaccination was given.

• Brand Name: BD ECLIPSE¿ NEEDLE 23 G X 1 IN. SINGLE USE STERILE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16301898
• Report Number: 8041187-2023-00050
• Device Sequence Number: 20315023
• Product Code: FMI
• UDI-Device Identifier: 00382903057627
• UDI-Public: 00382903057627
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305762
• Device Lot Number: 2069379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 02/04/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown